Manual for Surveillance of Events Supposedly Attributable to Vaccination or Immunization in the Region of the Americas

Abstract

One of the essential components of the safe vaccination system is the surveillance of events supposedly attributable to vaccination or immunization (ESAVI). This surveillance is aimed at early detection of any adverse events that may occur following immunization, in order to monitor and classify risks related to a vaccine, the manufacturing process, transportation, storage, administration, and any preexisting condition in the vaccinated person, and to rule out an association between the event and the vaccine. This manual has been adapted for the Region of the Americas from the Global Manual on Surveillance of Adverse Events Following Immunization, published by the World Health Organization in 2014. It provides a comprehensive technical review of all processes and procedures for applying and implementing high-quality ESAVI surveillance systems. It brings together the expertise of vaccine safety specialists from the Region and from around the world, experts from national immunization programs, national regulatory bodies, and other institutions that have developed relevant knowledge on surveillance of these events. It is hoped that this document will serve as a guide to provide national immunization program managers, pharmacovigilance officers of national regulatory authorities, and other institutions responsible for monitoring vaccine safety with tools to facilitate their task, enabling them to apply international standards to issues such as event detection, event investigation, causality assessment, management of ESAVI data, and risk communication.